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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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Axle Interspinous Fusion System - M697X08033261308PCSTR1

IRIX-A INTEGRATED SPACER ASSY, 33 X 26 X 8°, 13mm, PC (STERILE)
Xtant Medical Holdings, Inc.
X080-332613-08PC-STR
In Commercial Distribution

  • M697X08033261308PCSTR1 ()

  • Height: 13 Millimeter
  • Width: 33 Millimeter
  • Angle: 8 degree
  • Length: 26 Millimeter


  • Polymeric spinal fusion cage, sterile

Axle Interspinous Fusion System - M697X08033261308PC1

IRIX-A INTEGRATED SPACER ASSY, 33 X 26 X 8°, 13mm, PC
Xtant Medical Holdings, Inc.
X080-332613-08PC
In Commercial Distribution

  • M697X08033261308PC1 ()

  • Length: 26 Millimeter
  • Angle: 8 degree
  • Height: 13 Millimeter
  • Width: 33 Millimeter


  • Polymeric spinal interbody fusion cage

Axle Interspinous Fusion System - M697X080332613081

IRIX-A INTEGRATED SPACER ASSY, 33 X 26 X 8°, 13mm
Xtant Medical Holdings, Inc.
X080-332613-08
In Commercial Distribution

  • M697X080332613081 ()

  • Angle: 8 degree
  • Height: 13 Millimeter
  • Width: 33 Millimeter
  • Length: 26 Millimeter


  • Polymeric spinal interbody fusion cage

Irix-A Lumbar Integrated Fusion System - M697X08033261120TSTR1

IRIX-A INTEGRATED SPACER, TITANIUM, 33 X 26 X 20°, 11mm (STERILE)
Xtant Medical Holdings, Inc.
X080-332611-20T-STR
In Commercial Distribution

  • M697X08033261120TSTR1 ()

  • 26mm depth X 20°, 11mm height
  • Width: 33 Millimeter


  • Metallic spinal interbody fusion cage

Irix-A Lumbar Integrated Fusion System - M697X08033261116TSTR1

IRIX-A INTEGRATED SPACER, TITANIUM, 33 X 26 X 16°, 11mm (STERILE)
Xtant Medical Holdings, Inc.
X080-332611-16T-STR
In Commercial Distribution

  • M697X08033261116TSTR1 ()

  • Width: 33 Millimeter
  • 26mm depth X 16°, 11mm height


  • Metallic spinal interbody fusion cage

Axle Interspinous Fusion System - M697X08033261112X1

IRIX-A INTEGRATED SPACER ASSY, 33 X 26 X 12°, 11mm, CE MARKED
Xtant Medical Holdings, Inc.
X080-332611-12X
In Commercial Distribution

  • M697X08033261112X1 ()

  • Length: 26 Millimeter
  • Angle: 12 degree
  • Width: 33 Millimeter
  • Height: 11 Millimeter


  • Polymeric spinal interbody fusion cage

Axle Interspinous Fusion System - M697X08033261112TX1

IRIX-A INTEGRATED SPACER, TITANIUM, 33 X 26 X 12°, 11mm, CE MARKED
Xtant Medical Holdings, Inc.
X080-332611-12TX
In Commercial Distribution

  • M697X08033261112TX1 ()

  • Length: 26 Millimeter
  • Angle: 12 degree
  • Height: 11 Millimeter
  • Width: 33 Millimeter


  • Metallic spinal fusion cage, non-sterile

Axle Interspinous Fusion System - M697X08033261112TSTRX1

IRIX-A INTEGRATED SPACER, TITANIUM, 33 X 26 X 12°, 11mm (STERILE), CE MARKED
Xtant Medical Holdings, Inc.
X080-332611-12T-STRX
In Commercial Distribution

  • M697X08033261112TSTRX1 ()

  • Width: 33 Millimeter
  • Length: 26 Millimeter
  • Height: 11 Millimeter
  • Angle: 12 degree


  • Metallic spinal interbody fusion cage

Axle Interspinous Fusion System - M697X08033261112TSTR1

IRIX-A INTEGRATED SPACER, TITANIUM, 33 X 26 X 12°, 11mm (STERILE)
Xtant Medical Holdings, Inc.
X080-332611-12T-STR
In Commercial Distribution

  • M697X08033261112TSTR1 ()

  • Angle: 12 degree
  • Length: 26 Millimeter
  • Height: 11 Millimeter
  • Width: 33 Millimeter


  • Metallic spinal interbody fusion cage

Axle Interspinous Fusion System - M697X08033261112TPCX1

IRIX-A INTEGRATED SPACER, TITANIUM ASSY, 33 X 26 X 12°, 11mm, PC, CE MARKED
Xtant Medical Holdings, Inc.
X080-332611-12TPCX
In Commercial Distribution

  • M697X08033261112TPCX1 ()

  • Height: 11 Millimeter
  • Width: 33 Millimeter
  • Length: 26 Millimeter
  • Angle: 12 degree


  • Metallic spinal fusion cage, non-sterile
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